Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Novartis

Status and phase

Terminated

Phase 3

Conditions

Breast Cancer With Bone Metastasis

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00372710

CZOL446EDE03

Details and patient eligibility

About

Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion
No treatment with bisphosphonates within 6 months prior to inclusion into the study
Good health status (ECOG Performance status 0-2)

Exclusion criteria

Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening
Abnormal renal function
History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
Pregnancy and lactation
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)